Your session is about to expire
← Back to Search
Proteasome Inhibitor
Carfilzomib-based Chemotherapy for Multiple Myeloma (CarMob Trial)
Phase 1
Recruiting
Research Sponsored by Hackensack Meridian Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has a confirmed diagnosis of multiple myeloma as specified by the International Myeloma Working Group criteria and must have measurable disease as defined by at least one of the following criteria: Serum monoclonal protein ≥ 0.5 g/dL, ≥200 mg of monoclonal protein in the urine on 24-hour electrophoresis, Serum immunoglobulin free light chain: involved FLC ≥ 10 mg/dL (≥ 100 mg/L) AND abnormal serum immunoglobulin kappa to lambda free light chain ratio
Subjects must have completed any 'induction therapy' and have achieved less than a complete response (CR).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
CarMob Trial Summary
This trial is testing a new cancer drug, Carfilzomib, given with other drugs, to see what dose is safe for people.
Who is the study for?
This trial is for adults over 18 with multiple myeloma who have had some treatment but not a complete response. They should expect to live more than 12 weeks, be in fairly good health with normal liver function and heart performance, and have an acceptable blood count. Women must test negative for pregnancy and agree to use contraception, as must men.Check my eligibility
What is being tested?
The study tests different doses of Carfilzomib (20-70mg/m2) combined with Cyclophosphamide, Dexamethasone, and G-CSF in escalating groups using a '3+3 design' to find the best dose for stem cell transplant preparation in multiple myeloma patients.See study design
What are the potential side effects?
Carfilzomib may cause fatigue, nausea, shortness of breath, fever, and risk of infection. It can also affect blood pressure and heart rhythm. Side effects from Cyclophosphamide include hair loss, mouth sores while Dexamethasone can cause weight gain and mood swings.
CarMob Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have multiple myeloma with measurable indicators.
Select...
I finished my initial cancer treatment but didn't achieve total remission.
Select...
I am 18 years old or older.
Select...
I can do all or most of my daily activities without help.
CarMob Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Side effects data
From 2021 Phase 3 trial • 126 Patients • NCT0302923462%
Anaemia
49%
Upper respiratory tract infection
49%
Platelet count decreased
39%
White blood cell count decreased
38%
Hypertension
35%
Hypokalaemia
30%
Neutrophil count decreased
28%
Lymphocyte count decreased
23%
Pneumonia
21%
Cough
19%
Blood creatinine increased
19%
Insomnia
18%
Pyrexia
17%
Hyperuricaemia
17%
Diarrhoea
16%
Hypoalbuminaemia
16%
Hypocalcaemia
16%
Neutrophil count increased
16%
Blood lactate dehydrogenase increased
15%
Blood uric acid increased
15%
Blood pressure increased
15%
Lung infection
14%
Hyperglycaemia
14%
White blood cell count increased
14%
Blood bilirubin increased
14%
Blood glucose increased
14%
Constipation
12%
Blood urea increased
12%
Neutrophil percentage increased
11%
Alanine aminotransferase increased
11%
Hyponatraemia
11%
Hypercalcaemia
10%
Aspartate aminotransferase increased
10%
Blood potassium decreased
10%
Bronchitis
10%
Neuropathy peripheral
10%
Productive cough
10%
Oedema peripheral
10%
Lymphocyte percentage decreased
9%
Leukocytosis
8%
Blood phosphorus increased
8%
Influenza
8%
Blood albumin decreased
8%
Hypoproteinaemia
7%
Prealbumin decreased
7%
Bilirubin conjugated increased
7%
Peripheral swelling
7%
Nasopharyngitis
7%
Hypophosphataemia
7%
Back pain
7%
Abdominal distension
7%
Vomiting
7%
Cataract
7%
Mean cell volume increased
6%
Gamma-glutamyltransferase increased
6%
Hyperkalaemia
6%
Thrombocytopenia
6%
Vision blurred
6%
Respiratory tract infection
6%
Hepatic function abnormal
6%
Nausea
6%
Hypoglycaemia
3%
Plasma cell myeloma
3%
Acute kidney injury
2%
Bone pain
2%
Cardiac amyloidosis
2%
Localised infection
1%
Pain
1%
Periodontitis
1%
Myelopathy
1%
Device related infection
1%
Dysuria
1%
Pleural effusion
1%
Otitis media
1%
Pancreatitis acute
1%
Spinal compression fracture
1%
Lipoma
1%
Cerebral ischaemia
1%
Deep vein thrombosis
1%
Cardiac failure acute
1%
Soft tissue infection
1%
Nerve compression
1%
Chronic kidney disease
1%
Hypotension
1%
Asthma
1%
Bronchiolitis
1%
Pathological fracture
1%
Myolipoma
1%
Neuralgia
1%
Escherichia sepsis
1%
Interstitial lung disease
1%
Obstructive airways disorder
1%
Organising pneumonia
1%
Supraventricular tachycardia
1%
Disease progression
1%
Infusion site extravasation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carfilzomib With Dexamethasone
CarMob Trial Design
6Treatment groups
Experimental Treatment
Group I: Carfilzomib Mobilization - Dose Level 5Experimental Treatment4 Interventions
Carfilzomib at 70mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF.
For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Group II: Carfilzomib Mobilization - Dose Level 4Experimental Treatment4 Interventions
Carfilzomib at 56mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF.
For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Group III: Carfilzomib Mobilization - Dose Level 3Experimental Treatment4 Interventions
Carfilzomib at 45mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF.
For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Group IV: Carfilzomib Mobilization - Dose Level 2Experimental Treatment4 Interventions
Carfilzomib at 36mg/m2 over 30 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF.
For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Group V: Carfilzomib Mobilization - Dose Level 1Experimental Treatment4 Interventions
Carfilzomib at 27mg/m2 over 10 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF.
For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Group VI: Carfilzomib Mobilization - Dose Level 0Experimental Treatment4 Interventions
Carfilzomib at 20mg/m2 over 10 minutes will be administered concomitantly with Cyclophosphamide 2 gm/m2, Dexamethasone 40mg and G-CSF.
For patients who are naïve to carfilzomib based therapy a priming dose of Carfilzomib (20mg/m2) will be administered 1 week prior to the cohort dosing.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carfilzomib
2017
Completed Phase 3
~1310
Cyclophosphamide
1995
Completed Phase 3
~3770
Dexamethasone
2007
Completed Phase 4
~2590
Granulocyte Colony-Stimulating Factor
2016
Completed Phase 2
~50
Find a Location
Who is running the clinical trial?
AmgenIndustry Sponsor
1,384 Previous Clinical Trials
1,380,133 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,722 Patients Enrolled for Multiple Myeloma
Hackensack Meridian HealthLead Sponsor
132 Previous Clinical Trials
29,455 Total Patients Enrolled
20 Trials studying Multiple Myeloma
1,402 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have had a heart scan showing that your heart is pumping well within the last 6 months.I have not had radiation therapy in the last 3 weeks.Participants must have detectable levels of specific proteins in their blood or urine that can be measured.I do not have any uncontrolled illnesses like high blood pressure, diabetes, infections, or liver disease.I have multiple myeloma with measurable indicators.I finished my initial cancer treatment but didn't achieve total remission.Your body has enough white blood cells to fight off infections. If you have bone marrow biopsy showing a lot of myeloma, a lower count is okay.Your platelet count is at least 50,000 per cubic millimeter (or at least 30,000 for patients with a lot of myeloma in their bone marrow).I am 18 years old or older.I can do all or most of my daily activities without help.I have undergone stem cell transplant or preparation for it.I have moderate to severe nerve damage in my hands or feet.Your liver enzyme levels are not more than three times the normal limit.Your liver test results should show a certain level of a specific enzyme called SGPT/ALT.I haven't had cancer, except for certain skin cancers or low-risk prostate cancer treated fully, in the last 3 years.I agree to use two effective birth control methods if I'm sexually active.I agree not to donate sperm during and for 3 months after my carfilzomib treatment.I do not have any active infections or health issues that would make this treatment too risky for me.Your hemoglobin level is higher than 9.0 grams per deciliter.I have active HIV or active hepatitis A, B, or C.My high blood pressure is not under control.I have high blood pressure in the lungs.The level of bilirubin in your blood should be less than 1.5 times the upper limit of normal.If you are a woman who could become pregnant, you need to have a negative pregnancy test within a week before starting treatment and another negative test within 24 hours before taking the study drug.I do not have severe heart disease or recent heart attacks.
Research Study Groups:
This trial has the following groups:- Group 1: Carfilzomib Mobilization - Dose Level 4
- Group 2: Carfilzomib Mobilization - Dose Level 3
- Group 3: Carfilzomib Mobilization - Dose Level 5
- Group 4: Carfilzomib Mobilization - Dose Level 0
- Group 5: Carfilzomib Mobilization - Dose Level 1
- Group 6: Carfilzomib Mobilization - Dose Level 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger